Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence.

Female Stress Urinary Incontinence Clinical Trial

— CO2  

Official title:

Prospective, Open-Label, Multi-Center, Non- Comparative Study to Assess the Safety and Efficacy of CO2 Laser System (FemiLiftTM) in the Treatment of Stress Urinary Incontinence (SUI) in Female Subjects.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02981654
• Other study ID #: 2092-15-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 30, 2016
• Last updated: December 4, 2016
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: December 2016
• Source: Sheba Medical Center
• Contact: Yair Leopld
• Phone: 972-54-4847271
• Email: Yair.Leopold[@]almasurgical.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, multi-center, non-comparative study that will be conducted on female subjects between 30 and 75 years of age, diagnosed with stress urinary incontinence (SUI).

Following the screening period, including urodynamic assessment to confirm SUI, each subject will undergo three FemiLiftTM treatment sessions, and will be followed up for a period of one year. The main efficacy endpoint in this study is defined as significant improvement (score of 6 or 7) in the urinary incontinence measured with PGI-I score at the 6 months visit. Various subjective and objective measures of incontinence severity, quality of life, sexual function and tissue effects will be performed at follow up.

Description:

Improvement in SUI symptoms as measured by the following parameters:

Objective parameters:

• Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months:

• Number of incontinence episodes per day

• Number of pads used per day

• Change from baseline in 1 hour pad test 1, 2, 6 and 12 months

• Change from baseline as assessed with Vaginal Biopsy

Subjective parameters:

• Patient Global Impression of Severity (PGI-S) - 4-point Likert scale - at screening, 1, 2, 6 and 12 months

• Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) - at 1, 2, 6 and 12 months

• Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) - at 1, 2, 6 and 12 months

• Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) - at 1, 2, 6 and 12 months

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Females between 30 and 75 years of age

• Provided written Informed Consent

• Patients with mild to moderate stress urinary incontinence (SUI) [according to the severity index developed by Sandvik]

• Patients with mixed urinary incontinence, while the predominant symptoms are stress related, may also be enrolled

• Normal Papanicolaou smear (up to 1 year prior to screening)

• Negative urine culture

• Vaginal canal, introitus and vestibule free of injuries and bleeding

• Positive urinary stress test (Urine leakage is demonstrated while the patient is examined with full bladder in lithotomy position, and asked to perform 3 strong coughs).

Exclusion Criteria:

• Positive pregnancy test

• Planned pregnancy within the next year

• Severe prolapse (POP>= grade 3)

• Use of photosensitive drugs

• Injury or/and active infection in the treatment area

• Active vaginal infection

• human papillomavirus/herpes simplex virus

• Undiagnosed vaginal bleeding

• Urge or overflow incontinence

• Patients who are on antidepressants, or a-adrenergic and anticholinergic medications

• Patients with immune system diseases.

• Patients with allergic reaction to laser.

• Patient under treatment with photosensitivity side effects medication.

• Obese women (BMI >30)

• Patient unable to follow post treatment instructions.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Alma Lasers Pixel carbon dioxide laser system
The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	Kaplan Medical Center, The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate - SUI Symptom Improvement	Success rate - defined as an improvement in SUI symptoms as a score or 6 or 7 measured by the Patient Global Impression of Improvement (PGI-I) - 7-point Likert scale - at the 6 months visit	6 months	No
Secondary	Urinary Diary	Change from baseline in 3 days Urinary Diary - at 1, 2, 6 and 12 months post first treatment: Number of incontinence episodes per day	12 months	No
Secondary	1 hour pad test	Change from baseline in 1 hour pad test at 1, 2, 6 and 12 months post first treatment	12 months	No
Secondary	Vaginal Biopsy	Sample will be obtained from the vaginal mucosa 2 cm inside the introitus on the lateral vaginal wall.	12 months	No
Secondary	PGI-S	Change from baseline in Patient Global Impression of Severity (PGI-S) over time	12 months	No
Secondary	PFDI	Change from baseline in Pelvic Floor Distress Inventory Questionnaire (PFDI) over time	12 months	Yes
Secondary	PISQ	Change from baseline in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) over time	12 months	No
Secondary	PFIQ	Change from baseline in Pelvic Floor Impact Questionnaire (PFIQ) over time	12 months	No
Secondary	Safety Endpoint assessed by the rate of serious device related adverse events	The rate of serious device related adverse events reported during the study	12 months	No